New Haven, CT – Gaucher disease treatment has come a long way in the past three decades. The United States Food and Drug Administration (FDA) approved the first enzyme replacement therapy (ERT) in 1991. That first approval opened the door for other ERT treatments and paved the road for substrate...
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SYDNEY – Kazia Therapeutics Limited (ASX: KZA; NASDAQ: KZIA), an oncology-focused drug development company, is pleased to inform stakeholders that the GBM AGILE study in glioblastoma (NCT03970447) has opened at Sunnybrook Health Sciences Centre in Toronto, Ontario. This marks the first Canadian site to open to paxalisib, and the first...
YONGIN, South Korea — GC Biopharma (006280. KS) and Novel Pharma have announced that the U.S. FDA has cleared the investigational new drug (IND) application for their jointly developed MPSIIIA (Sanfilippo Syndrome Type A) treatment, GC1130A. With this FDA clearance, the development of GC1130A is set to accelerate, with multinational...
YOGIN, South Korea — GC Biopharma Corp today announces that the US Food and Drug Administration (FDA) has approved ALYGLO (immune globulin intravenous, human-stwk) 10% Liquid, formerly referred to as “GC5107,” for the treatment of adult patients aged 17 years and older with primary humoral immunodeficiency (PI). The ALYGLO pivotal...
GC Biopharma Corp., a leading provider of biopharmaceutical products in South Korea, announced today that it has signed an Asset Purchase Agreement with Catalyst Biosciences to acquire 3 programs related to the orphan hematology disorders
Boston, Mass. – Positive high-level results from a global, randomised, double-blind, placebo-controlled Phase III trial in adults with anti-acetylcholine receptor (AChR) antibody-positive (Ab+) generalised myasthenia gravis (gMG) showed that gefurulimab met its primary and all secondary endpoints. Data demonstrated a statistically significant and clinically meaningful improvement from baseline in Myasthenia...
Gemcitabine plus cisplatin significantly improved overall survival (OS) when compared with fluorouracil plus cisplatin in treatment-naïve patients with advanced nasopharyngeal carcinoma, according to final results of a phase 3 study published in the Journal of Clinical Oncology.¹ The GEM20110714 trial (ClinicalTrials.gov Identifier: NCT01528618) enrolled 362 patients who were randomly assigned 1:1...
DRESDEN, Germany – GEMoaB, a biopharmaceutical company focused on the development of next-generation immunotherapies for hard-to-treat cancers, today announced the publication of clinical data obtained from the ongoing Phase I study of their rapidly switchable UniCAR platform lead asset, UniCAR-T-CD123, in relapsed/refractory acute myeloid leukemia (rrAML), in the journal “Blood”. The...
Uppsala, Sweden – Women with a type of ovarian cancer known as germ cell tumors have a worse prognosis than men with similar tumours, i.e. testicular cancer. After five years with the disease, 98 percent of men were alive while the survival rate for women was only 85 percent. This...
HOUSTON — As stroma – the supportive framework of the prostate gland – react to prostate cancer, changes in the expression of genes occur that induce the formation of new structures such as blood vessels, nerves and parts of nerves, said researchers at Baylor College of Medicine in a report...